Partnerships: pharma is closer than you think

Different forms of partnership

Companies can pay for staff already employed by the NHS or they can supply their own staff to the NHS. In Portsmouth general practices wrote to patients with stomas and offered them an appointment with a nurse employed by the stoma company Salts Medilink to “optimise stoma care.”

Another response to a freedom of information request said that in Croydon Pfizer paid for a “medicines optimisation heart failure cardiac pharmacist post” for 2013-14, seconded from the NHS, to “review the GP records of patients with heart failure in 28 general practices. The pharmacist provided recommendations to GPs regarding the initiation and optimisation of the doses or medications for cardiovascular disease” as well as “education to GPs regarding the importance of optimisation medications to improve the quality of life, reduce exacerbations and reduce hospital admissions.”

Alternatively, drug companies can pay an intermediary company to provide prescribing support. In many areas pharmacists from one such company, Interface Clinical Services, reviewed the records of patients who had osteoporosis (paid for by ProStrakan, which makes calcium and vitamin D products) or atrial fibrillation (paid for by Bayer, which makes anticoagulants).

Interface has trusted “NHS business partner” status3 and told The BMJ that it follows prescribing guidance from the National Institute for Health and Care Excellence (NICE). Its stated plan is in the first year to do “active case finding” of osteoporosis; in year two it performs “expansion of risk factors from year one to assist in early case finding.”4 Interface claims that this work will save £1m by increasing prescribing of drugs, in turn preventing 100 hip fractures in patients of 48 general practices in one clinical commissioning group over four years.

Pharmacists working for Interface had access to patients’ records but practices did not seek permission from individual patients, responses to my freedom of information requests show. Central Manchester CCG, for example, used an Interface pharmacist paid for by Bayer. It said, “The patients were not informed of the pharmacists reviewing the notes. This is not necessary under current regulation.”

Steve Davis, the company’s director, said that Interface has worked in almost half of UK general practices in the past decade.

“Many of our services would involve gathering the information required to show a GP why a patient appears to be optimally or suboptimally managed in relation to best practice guidance,” he told The BMJ.

“This might be something as simple as creating a list of patients with diabetes, showing the GP which patients are missing which of the NICE nine key care processes, and making recommendations that the missing care processes are put in place. Or if a care process indicates that a patient is over target on cholesterol, a recommendation might be made about what to do about this based on patient history and current treatment strategy.”

However, he pointed out that these would be “purely . . . recommendations based on best practice guidance: whether the recommendations are acted upon is entirely the decision of the GP.” He is also clear that “it would always be made clear to patients that we have been invited to the practice to perform a specific task under the clear direction of the authorising GP.”

While this may be the case when company professionals meet the patient, it will not necessarily be so when they review notes and make recommendations to the doctor.

Industry’s view

The Association of the British Pharmaceutical Industry (ABPI) is in favour of companies “being able to support products appropriately,” David Watson, its director of pricing and reimbursement, told The BMJ. Before the Quality and Outcomes Framework was introduced a decade ago GPs did not have incentives to look for patients with atrial fibrillation, high cholesterol, or diabetes.

Watson also said that audits were not simply about increasing prescribing volume. The projects should not “be designed to result in only one particular company benefiting or patients all being switched over wholesale onto these new drugs. I wouldn’t accept them as being overtly as commercial as that.”

Does the fact that the staff making these recommendations are ultimately being paid by the drug industry create a conflict of interest? Watson says not because “barriers to uptake of new anticoagulants are often not to do with identifying eligible patients” but more to do with guidelines, and “having nurses looking at patient records” wouldn’t have any effect on whether a product was recommended by the guideline. And what about access to records? “It would absolutely be the case that pharmaceutical companies sponsoring would not have accessed any patient data whatsoever.”

Watson is satisfied with partnerships as long as conflicts of interest are well managed: “We think it [partnership] is a good thing all round, but there must always be clear governance and the nature of the agreement should always be transparent, with the patient’s best interests in mind,” he said.

Many general practices in Scotland have also been contacted with offers to use intermediate companies in prescribing management, and some have taken them up. However, in Scotland there are long established relationships with pharmacists employed by health boards, who work with practices and help in drugs rationalisation and management.

Margaret Ryan is a pharmacist and the lead clinician for NHS Greater Glasgow and Clyde Health Board as well as chair of the Scottish Prescribing Advisers Association. She is working on guidance for general practices, which have not always understood that industry sponsored companies and staff were not part of the local NHS pharmacy team.

“Presently there is no specific requirement for these individuals to communicate with the health board to provide assurance on governance issues such as working practices, responsibility for decisions, validity of protocols, or whether they work within health board prescribing guidelines. This raises our concerns regarding safety, quality, and cost effectiveness of their work, which is funded through an external source, most likely the pharmaceutical industry.”

Government and health service policy

Many NHS organisations have a policy on joint working with industry. Bury CCG’s policy says that the aim is “to promote closer working relationships between industry and the NHS.”5

In 2009, the ABPI proposed “joint working” with the NHS, noting, “The NHS is under pressure and changing rapidly. Many, including some UK governments, want the NHS to engage with the pharmaceutical industry on a broader business-to-business agenda.”6 The Department of Health and the ABPI created the “moving beyond sponsorship” toolkit in 2010.7 This described a new era in which “goals are distinctly different from sponsorship . . . goals are agreed jointly by the NHS organisation and company, in the interest of patients, and shared throughout the project.”

One principle is that “each party should be entitled to benefit from this arrangement.” The toolkit was commissioned by the Ministerial Industry Strategy Group, whose members comprise four ministers (from the Department of Health, the Department for Business Innovation and Skills, and the Treasury) and eight representatives of the drug industry. It exists to bring “together government and the research-based bio-pharmaceutical industry to promote a strong and profitable UK-based pharmaceutical industry.”8

Jointly run roadshows

Roadshows jointly run by NHS England and the ABPI, aimed at primary care professionals, are another push to work with industry.13 One aim is to clarify the Pharmaceutical Price Regulation Scheme (PPRS).

When industry agreed to the current PPRS the health secretary told industry and NHS England that they “should work together on a joint programme to look at how medications were best used,” Watson explained.

The PPRS was negotiated in the context of austerity, with industry agreeing to cap spending on branded drugs for the first two years and increase spending by less than 2% a year in the following three years. He estimates that pharma will pay back around £4bn over the course of the deal.

The NHS is “good at using medicines that are older and off-patent, but there is a particular challenge to use new medicines,” said Watson, explaining that the ABPI wants “finance leads in the CCGs to understand that there is money in the system that is being paid by industry . . . to allow for growth in branded medicines use.”

Professional concerns

Dean Marshall, from the BMA’s General Practitioners Committee, has some concerns. “The situation where staff are supplied by a third party that might gain from the switch—for example, if provided by a drug company—requires careful consideration, and it is important for them to be divorced from the clinical decision making process, with their work confined to implementing change agreed by clinicians,” he said. “Whatever happens, GPs must remember that they are ultimately responsible for the prescribing and should not feel coerced into making changes that are not in the best interests of patients.”

The Royal Pharmaceutical Society said that it “supports person centred holistic medication review that puts the patient or their carer’s views and wishes and the forefront of decision about their care.

“We would not support medication reviews funded by the NHS or pharmaceutical industry that do not have this principle at the heart of the care being provided.”

The head of nursing practice at the Royal College of Nursing, JP Nolan, acknowledged the “intermediate companies and other complex employment structures” affecting nurses and told The BMJ that although these structures “do not in themselves compromise” professionals, “the NMC [Nursing and Midwifery Council] code is quite clear in terms of obligations when practising, including . . . the promotion of, or recommendation of, products and services.

“Some members who have worked within third, or indeed fourth and fifth party structures,” he said, “have found it difficult to identify . . . which company or subsidiary to raise concerns with.”

Patients’ concerns

A key concern is whether patients have been properly informed about the origin of some of the professionals scrutinising their records for deviations from treatment guidelines. NHS England ran a workshop with patients and carers on taking prescription drugs in 2013, but the question of whether drug companies can be trusted with a role in drug management was not noted to have been discussed.14

Jeremy Taylor, chair of National Voices, which promotes patients’ interests, doesn’t have a problem in principle with pharma encouraging uptake of approved drugs that work; however, he is more concerned about intermediate companies and pharma sponsored professionals. “This is a questionable practice which could undermine the relationship of trust between doctor and patient and the principles of informed, shared decision making. As a patient, I want medical advice to come from my doctor and from other relevant clinicians that I have chosen, or have consented to be involved in my care. I don’t want someone who is not part of my clinical team having access to my records, without my consent, and seeking to influence decisions about my treatment, especially if that person has a commercial motive to advocate a particular treatment option.

“At the very least I would expect to be informed that such an arrangement was being proposed and for the doctor to seek my consent first.”

Individual consent for pharma funded review of patients’ notes isn’t happening. Croydon CCG described the contract of a Pfizer sponsored pharmacist as a “deed of contract,” which it says means that “the accessing of the record was no different than if the GP had undertaken the review, or if the pharmacist was employed by the GP and undertook the review.” But patients have not been asked if they see it this way.

Some may doubt the wisdom of new working relationships with drug companies when we have ongoing systemic problems. For example, disclosure of industry funding to professionals has widespread support15 but will happen only from 2016 and with consent of the recipient. Not all clinical trials are published, meaning we cannot know that guidelines are based on the best possible evidence.

If industry finances more drug optimisation projects, what effect might it have on the NHS pharmacy services that normally do this work? Will it mean that the only drugs optimisation work available promotes drug switches that are profitable to industry?

One of Pfizer’s stated aims from partnership working is to “Develop a deeper insight and understanding of the NHS.”16 Are we sure we’re getting a fair exchange for this intelligence gathering?